Clearance Summary
TEST, C-REATIVE PROTEIN, LATEX SLIDE received FDA 510(k) clearance under submission number K760035, sponsored by Gamma Biologicals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1976-08-03.
- Submission: K760035
- Applicant / Sponsor: Gamma Biologicals, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 1976-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.